Recalls / Class III
Class IIIF-1371-2019
Product
Item FG 10079, Barleans, Flax Oil, 100 Softgels per bottle. UPC 7 05875 1007 6. Item FG 10081, Barleans, Lignan Flax Oil, 250 Softgels per bottle. UPC 7 05875 10008 3. Item FG 70000, Barlean's, Pure Flax Oil, 45 Softgels per bottle, label in English and Bulgarian. UPC 7 05875 14004 1.
- Type
- Food
- Affected lot / code info
- Best By of January 2022 and earlier
- Quantity
- 667 bottles (Item FG 10079); 1058 bottles (FG 10081); Firm did not provide for FG 7000
Why it was recalled
Barlean's dietary supplement product is recalled due to undeclared Sulfites. Sulfite levels of finished goods does not exceed 10 ppm.
Recalling firm
- Firm
- Barlean's Llc
- Notification channel
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Type
- Voluntary: Firm initiated
- Address
- 3660 Slater Rd, Ferndale, Washington 98248-9518
Distribution
- Distribution pattern
- nationwide
Timeline
- Recall initiated
- 2019-05-06
- FDA classified
- 2019-05-16
- Posted by FDA
- 2019-05-22
- Terminated
- 2020-10-15
- Status
- Terminated
Source: openFDA Food Enforcement endpoint. Recall record F-1371-2019. The FDA issues recall classifications as health-hazard assessments, not legal findings.